Rationale for placebo in research
The placebo response
Placebo is a pharmacologically inactive compound that produces drug like desirable effects (as well as side effects) in patients. Placebo effect can be understood as a way to deceive a patient into believing that he or she was given a real drug, however some patients who are aware of the inertness of the compound also get placebo effects. This can be explained by the psycho-neuro-physiological impact of the immune system and the brain’s role in physical health. The subjective outcome of the treatment is often different from it’s objective visible impact. Placebo expresses the mysticism of the human mind’s ability to make use of faith in the healing process and generate a therapeutic effect even in the absence of an active drug.
Placebo in psychiatry drug trials
Needless to say clinical pharmacological research on human subjects has legal and ethical considerations. The validity of informed consent is a matter of higher concern in psychiatry than any other. Midst all of this, the use of placebo in a psychiatric condition in spite of the availability of a known effective drug raises even more bioethically complex questions. With the Hippocratic oath compelling the physician to ‘do no harm’, witholding of an efficacious treatment becomes a grey area that requires much lucidity to assure appropriateness. The use of placebo in psychiatry trials thus requires additional sensitivity and study.
Rationale for placebo
Placebo effect is different in different illnesses. Psychiatric illnesses improve or worsen with a range of non pharmacological interventions anyways (family relationships, social change, counseling, faith etc.) In these cases the placebo effect can offer significant improvement too. Thus it is essential to balance the efficacy of a new drug with that of an active control as well as placebo to discern it’s true safety and efficacy. Informed consent from the patient assures the ethicality and patients are explained the double blind nature of randomization. Also the impact of malingering and false reporting can alter response statistics. Stringent methods of control are required in psychiatry research to negate these limitations. Standardized doctor patient communication is also mandatory; we often see clinical effects with placebo and lack of therapeutic effect with the active drugs thus skewing the findings. Detailed understanding of placebo from practicing psychiatrists can be enlightening for the clinical trial staff.